Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
ABIRPRED
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
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For the treatment of metastatic, castrate-resistant prostate cancer (mCRPC) in combination with androgen deprivation therapy (ADT) and prednisone, in patients who are asymptomatic or mildly symptomatic after failure of ADT, and have not received prior chemotherapy.
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For the treatment of mCRPC in combination with ADT and prednisone, in patients who have progressed after prior chemotherapy containing docetaxel.
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In combination with prednisone and ADT for the treatment of patients with newly diagnosed hormone-sensitive high-risk metastatic prostate cancer who may have received up to 3 months of prior ADT (not funded by EAP).
abiraterone
Exceptional Access Program
(abiraterone - Metastatic castrate-resistant prostate cancer, according to specific criteria)
(EAP Website)
prednisone
ODB - General Benefit
(prednisone)
(ODB Formulary
)
Metastatic castration-resistant prostate cancer*:
| abiraterone | 1000 mg | PO | once daily |
|
prednisone 1 | 10 mg | PO | once daily |
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Newly diagnosed hormone-sensitive high-risk metastatic prostate cancer*: |
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| abiraterone | 1000 mg | PO | once daily |
| prednisone | 5 mg | PO | once daily |
*Patients should continue to receive a GnRH agonist during abiraterone treatment unless they have had prior orchiectomy.
Control hypertension and correct hypokalemia before treatment.
Patients may require increased corticosteroid dosage before, during and after periods of unusual stress such as surgery or trauma.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
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Toxicity
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Abiraterone Dose
|
Prednisone Dose |
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ALT or AST >5 x ULN OR Total bilirubin >3 x ULN |
Hold; monitor liver function closely until recovery to baseline then restart at 500mg once daily. Discontinue at recurrence. |
No change. |
| ALT or AST >20 x ULN | Discontinue permanently. | Not applicable. |
|
ALT or AST >3 x ULN AND Total bilirubin >2 x ULN (in the absence of biliary obstruction or other causes) |
||
| Myopathy/rhabdomyolysis | ||
| Confirmed pneumonitis/allergic alveolitis | ||
| Hypokalemia persists despite optimal K supplements and adequate oral intake | No change. | If on 5 mg/day, may increase to 10 mg/day. |
| Other mineralocorticoid effects persist |
Hepatic Impairment
Increased exposure and half-life have been observed in patients taking abiraterone with hepatic impairment at baseline.
| Hepatic Impairment (at baseline) | Abiraterone Dose | Prednisone Dose |
| Mild (Child-Pugh Class A) | No dose adjustment required | No dose adjustment required |
| Moderate (Child-Pugh Class B) | Do not use abiraterone |
|
| Severe (Child-Pugh Class C) |
Renal Impairment
No dose adjustment required for prednisone or abiraterone.
Dosage in the Elderly
No overall differences in effectiveness or adverse effects were seen between elderly and younger patients.
Refer to abiraterone, prednisone drug monograph(s) for additional details of adverse effects
|
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
|
|
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Refer to abiraterone drug monograph(s) for additional details
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Avoid co-administration with CYP2D6 substrates with narrow therapeutic range due to increased risk of toxicity. If must co-administer, consider dose reduction of 2D6 substrate.
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Avoid strong CYP3A4 inducers due to risk of reduced abiraterone efficacy.
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Avoid spironolactone as this may stimulate disease progression.
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Avoid use with radium 223 dichloride due to increased risk of fractures and mortality.
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Caution when co-administered with drugs that increase risk of myopathy/rhabdomyolysis.
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Use with caution in patients with diabetes as isolated cases of hypoglycemia has been reported post marketing, particularly in patients receiving concomitant therapy with pioglitazone or repaglinide.
Refer to abiraterone, prednisone drug monograph(s) for additional details.
Administration
Abiraterone
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Abiraterone must be taken on an empty stomach. No solid or liquid food should be eaten for at least 2 hours before and at least 1 hour after the dose.
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The tablets should be swallowed whole with a glass of water.
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If an abiraterone dose is missed, the dose should be skipped and the next dose taken as scheduled. Patients should not double the dose to make up for the missed one.
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Since abiraterone may harm the fetus, women who are pregnant or who may become pregnant should handle abiraterone with protection (e.g. gloves).
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Store at 15-30°C.
Contraindications
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Patients who have a hypersensitivity to this drug or any of its components
Other Warnings/Precautions
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Patients with pre-existing moderate or severe hepatic impairment should not receive abiraterone. Patients with moderate to severe hepatic impairment, active hepatitis, chronic liver disease or ascites were excluded from clinical trials.
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Use with caution in patients with cardiovascular disease as they were not included in clinical trials. Increased mineralocorticoid levels from CYP17 inhibition may cause hypertension, hypokalemia and fluid retention. Use with caution in patients whose underlying medical conditions may be affected by these effects.
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Caution is advised if patients need to be withdrawn from prednisone. Monitoring for adrenocortical insufficiency should occur.
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Adrenal insufficiency has been reported in patients taking abiraterone and prednisone. Increased corticosteroid dosage may be required before, during and after the stressful situation.
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Contains lactose and should not be used in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
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Efficacy may be lower in patients who have been treated previously with ketoconazole for their prostate cancer.
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The safety and efficacy of combination abiraterone and cytotoxic chemotherapy use has not been established.
Pregnancy/Lactation
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Abiraterone is contraindicated and not for use in women. Adequate contraception should be used by both sexes during treatment, and for at least 1 week after the last dose. Barrier contraception (including condoms) should be used.
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Breastfeeding is not recommended.
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Fertility Effects: Observed in animal studies (may be reversible)
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
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Blood pressure, serum potassium, fluid retention; Baseline and monthly
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Liver function tests, bilirubin; Baseline, every 2 weeks for the first 3 months and monthly thereafter, or as clinically indicated
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Monitor for adrenal insufficiency; As clinically indicated when prednisone is withdrawn, or during periods of infection/stress
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Monitor for mineralocorticoid excess; As clinically indicated if patient continues on abiraterone after stopping prednisone
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Blood glucose levels in patients with pre-existing diabetes receiving concomitant pioglitazone or repaglinide; Baseline and as clinically indicated
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Clinical toxicity assessment for infection, hot flashes, steroid side effects, gastrointestinal, dermatological, musculoskeletal, urinary, cardiac and respiratory effects; At each visit
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Cholesterol and triglycerides; Baseline, every 2 to 3 months and as clinically indicated
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Abiraterone drug monograph, Ontario Health (Cancer Care Ontario).
de Bono JS., Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med 2011;364:1995-2005.
Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Engl J Med. 2017 Jul 27;377(4):352-60.
Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013;368(2):138-48.
January 2023 Updated References section; reformatted Rationale/uses section for clarity
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.